Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 12 of 87
Nephron Sc Inc
Class II Terminated
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 048...
Reason: cGMP Deviations: deviations leading to potential cross-contamination.
D-1354-2022 August 24, 2022 West Columbia, SC
Nephron Sterile Compounding Center LLC
Class II Terminated
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12...
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
D-1344-2022 August 24, 2022 West Columbia, SC
Nephron Sterile Compounding Center LLC
Class II Terminated
PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Colum...
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
D-1346-2022 August 24, 2022 West Columbia, SC
Nephron Sterile Compounding Center LLC
Class II Terminated
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Out...
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
D-1345-2022 August 24, 2022 West Columbia, SC
Nephron Sterile Compounding Center LLC
Class II Terminated
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street E...
Reason: CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
D-1347-2022 August 24, 2022 West Columbia, SC
MEDEK LLC
Class I Terminated
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC C...
Reason: Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
D-1342-2022 August 24, 2022 Alamo, TX
Vi-Jon, LLC
Class II Terminated
Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3 21130-78060 1 Distributed By Better Living Brands LLC P.O. Box 99, Pleas...
Reason: Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
D-1244-2022 July 27, 2022 Smyrna, TN
Vi-Jon, LLC
Class I Terminated
CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 30594 2.
Reason: Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
D-1175-2022 July 13, 2022 Smyrna, TN
Buzzagogo, LLC
Class I Terminated
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Code 860002022116
Reason: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.
D-1160-2022 July 6, 2022 Nottingham, NH
Green Pharmaceuticals, Inc.
Class I Terminated
SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3
Reason: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
D-1165-2022 July 6, 2022 Camarillo, CA
Grato Holdings, Inc.
Class II Terminated
Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15
Reason: Microbial contamination of non-sterile product.
D-0991-2022 June 15, 2022 Woodbine, IA
Grato Holdings, Inc.
Class II Terminated
Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3
Reason: Microbial contamination of non-sterile product.
D-0989-2022 June 15, 2022 Woodbine, IA
Grato Holdings, Inc.
Class II Terminated
Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15
Reason: Microbial contamination of non-sterile product.
D-0990-2022 June 15, 2022 Woodbine, IA
Plastikon Healthcare LLC
Class I Completed
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI ...
Reason: Microbial Contamination of Non-Sterile Products
D-0867-2022 May 25, 2022 Lawrence, KS
Plastikon Healthcare LLC
Class I Completed
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals,...
Reason: Microbial Contamination of Non-Sterile Products
D-0868-2022 May 25, 2022 Lawrence, KS
Fagron, Inc
Class I Completed
SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
Reason: Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
D-0856-2022 May 18, 2022 Saint Paul, MN
Best Brands Consumer Products, Inc.
Class I Terminated
The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02
Reason: Chemical Contamination; FDA analysis found product to contain benzene
D-0877-2022 May 11, 2022 New York, NY
Best Brands Consumer Products, Inc.
Class I Terminated
Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-013-02
Reason: Chemical Contamination; FDA analysis found product to contain methanol
D-0876-2022 May 11, 2022 New York, NY
Unilever United States Inc.
Class I Ongoing
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans (UPC 0 79400 75150 8), and b) 6 oz. cans (UPC 0 79400 78490 2), Dist. By Unileve...
Reason: Chemical contamination: presence of benzene
D-0210-2024 May 4, 2022 Englewood Cliffs, NJ
VIRGIN SCENT INC
Class I Terminated
artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
Reason: Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
D-0782-2022 April 27, 2022 Gardena, CA
Blaine Labs Inc
Class I Terminated
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC...
Reason: Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
D-0668-2022 March 30, 2022 Santa Fe Springs, CA
Tennessee Technical Coatings, Corp.
Class I Terminated
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-...
Reason: Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
D-0739-2022 March 30, 2022 Lewisburg, TN
Golden State Medical Supply Inc.
Class II Terminated
Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
Reason: CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
D-0654-2022 March 23, 2022 Camarillo, CA
Direct Rx
Class II Terminated
Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
Reason: CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
D-0650-2022 March 16, 2022 Dawsonville, GA
Direct Rx
Class II Terminated
Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
Reason: CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
D-0651-2022 March 16, 2022 Dawsonville, GA